Z-0694-2019 Class II Terminated
FDA device recall Z-0694-2019 was initiated by Philips Medical Systems Nederlands on Dec 3, 2018 and is designated Class II. Reason for recall: During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement. The recall status is terminated (terminated May 12, 2020). Affected quantity: 35.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 16, 2019
- Initiation Date
- Dec 3, 2018
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
Product Description
Ingenia Elition S, Ingenia Elition X
Reason for Recall
During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.
Distribution Pattern
CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.
Code Information
Software version R5.5.0 Serial numbers: 45027 45011 45010 45024 45032 45026 45054 45035 45051 45052 45007 45043 45044 45031 45039 45025 46001 45033 45050 45034 45049 45037 45048 46004 45046 45008 45058 45028 45029 45030 45042 46005 46011 45040 45045
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0694-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026